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NCT01485419 Clinical Trial

Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

Traumatic Injury Clinical Trial

Official title:
Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01485419
Other study ID # NTI early sex hormone trial
Secondary ID
Status Completed
Phase N/A
First received December 1, 2011
Last updated March 28, 2017
Start date January 2011
Est. completion date December 2012

Study information
Verified date March 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Traumatic injury is a major public health problem with an immense societal cost. Despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. Evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. Determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. The goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.

Recruitment information / eligibility
Status Completed
Enrollment 292
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

Injury, ICU admission

Exclusion Criteria:

Isolated TBI, Admission beyond 6 hours

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States UPMC Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Multiple Organ Failure 7 days
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